FDA nod for Daybue, first treatment for Rett syndrome

11 March 2023

The US Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older.

The drug approval was granted to Acadia Pharmaceuticals (Nasdaq: ACAD), which says that Daybue is the first and only drug approved for the treatment of Rett syndrome, and is expected to be available in the USA by the end of April, 2023.

SVB Securities analysts have previously estimated that trofinetide could achieve $500 million-$1 billion in peak sales.

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